contraceptives--postcoital and dienogest

Fifty eight fertile female volunteers between 20 to 45 years were enrolled in a clinical trial to evaluate the efficacy and tolerance of the progestin dienogest (17 alpha-cyanomethyl-17 beta-hydroxyestra-4,9-dien-3-one, VEB Jenapharm Jena GDR) as a postcoital contraceptive. An oral dose of 2 mg dienogest was administered immediately after each coitus. The 58 women reported 872 intercourses during 302 cycles. Frequency of ingestion was on average 3 times per cycle. Pregnancy occurred in 14 women corresponding to a Pearl-index of 55.6. The observed pregnancy rate referring to all intercourses was 1.6 per cent. The incidence of expected pregnancies in relation to the coital exposures was 4.04 per cent. As a result the risk of pregnancy was reduced 2.5 times by dienogest. Menstrual disorders occurred in 18.9 per cent in regard of the total numbers of cycles. The results and an overview of literature suggest that neither dienogest nor other progestins are suitable as a sole contraceptive method when used as a postcoital agent. They are only indicated as a risk-reducing method after so-called "contraceptive emergencies".

Topics: Adult; Clinical Trials as Topic; Contraceptives, Postcoital; Contraceptives, Postcoital, Hormonal; Female; Humans; Menstrual Cycle; Middle Aged; Nandrolone; Pregnancy

Adult, female baboons (Papio hamadryas) were administered orally once 18 h p.c., either 1.6 mg STS 557 (17 alpha-cyanomethyl-17 beta-hydroxy-estra-4;9(10)-dien-3-one) or 1.6 mg levonorgestrel. Investigations of the bone-marrow cells of these animals showed, compared to untreated controls, no signs of increased chromosome aberrations caused by the substances. The relative frequency of chromosome aberrations were estimated for controls: STS 557: levonorgestrel with 0.60 +/- 0.35 : 0.55 +/- 0.39 : 0.92 +/- 0.46%, respectively. The differences between the three groups investigated in the exact Fisher-test (2 alpha = 0.05) were not significant.

Topics: Animals; Bone Marrow Cells; Chromosome Aberrations; Contraceptives, Oral, Combined; Contraceptives, Postcoital; Female; Humans; Levonorgestrel; Nandrolone; Norgestrel; Papio; Progesterone Congeners; Stereoisomerism

Estradiol-17 beta, progesterone, LH and FSH levels in plasma were measured simultaneously by radioimmunoassay and BBT was recorded in order to investigate the effect of a single midcycle oral dose of 0.5 or 2.0 mg dienogest (17 alpha-cyanomethyl-17 beta-hydroxy-estra-4,9-dien-3-one, VEB Jenapharm, Jena/GDR) on pituitary and ovarian function in 18 healthy fertile females. After application of 0.5 mg dienogest in the follicular phase the cycles appeared to be anovulatory. Administration of 2.0 mg two days prior to the expected LH-surge produced a delay of the LH-peak combined with an absence of ovulation as well as the absence of the normal subsequent increase of progesterone. With 0.5 mg the delay of the LH-surge was followed by an ovulation with normal corpus luteum function. The application of 0.5 or 2.0 mg one day before or during the rising LH-peak lowered the LH-surge but ovulation and luteal phase were not altered. Administration of both dosages during the LH-peak could neither prevent ovulation nor disturb corpus luteum function. Postovulatory ingestion of 0.5 or 2.0 mg dienogest during the BBT-rise produced no alteration of the further cycle. These results demonstrate that dienogest in a single-dose-administration in midcycle can alter pituitary and ovarian function depending on the time interval between application and the day of LH-surge.

Topics: Adult; Body Temperature; Contraceptives, Postcoital; Estradiol; Female; Follicle Stimulating Hormone; Humans; Luteinizing Hormone; Menstruation; Nandrolone; Ovary; Pituitary Gland; Progesterone

One single does of 0.4 mg of steroid compounds Levonorgestrel (13-ethyl-17alpha-ethinyl-17beta-hydroxy-gon-4-en-3-on) or STS 557 (17alpha-cyanomethyl-17beta-hydroxy-13beta-methylgona-4.9-dien-3-on) was administered to each of six baboon mothers, right after mating. No indication whatsoever to possible mutagenic action of the compounds applied under the given experimental conditions were recordable from the bone-marrow cells of the mothers nor from the lymphocytes of peripheral blood of their newborns. Chromosomal aberrations recorded from this species were within normal limits.

Topics: Animals; Bone Marrow Cells; Chromosome Aberrations; Chromosome Mapping; Contraceptives, Postcoital; Contraceptives, Postcoital, Synthetic; Female; Levonorgestrel; Lymphocytes; Nandrolone; Norgestrel; Papio; Pregnancy

A postcoital interceptive action of STS-557, a synthetic progestin, has been reported in the mouse, rat, and baboon. In the present study we reinvestigated the effects in the baboon with a modification of the original protocol: prolongation of the mating period from 6 to 48 hours. The time of mating was determined by observation of the perineal sex skin and the pattern of plasma estradiol in the periovulatory period. STS-557 (0.4 mg) was administered 6 hours after the initiation of mating, which was continued for an additional 42 hours. Controls received an empty gelatin capsule in the same mating protocol. Conception rate in the control baboons (n = 20) was 25%; in the STS-557-treated baboons (n = 18) it was 22%. There was also no difference in the pattern of plasma estradiol and progesterone in control versus treated baboons, either in pregnant or in nonpregnant animals. All pregnancies were normal. In light of the earlier report of effective postcoital action in the baboon from a single administration of STS-557 after a breeding period limited to 6 hours, our results indicate that the effect of a single dose is brief, and may not be clinically useful.

Topics: Animals; Contraceptives, Oral; Contraceptives, Postcoital; Estradiol; Female; Nandrolone; Papio; Progesterone; Progesterone Congeners